EP1470836A1 - Implantable active medical device like a cardiac stimulator, defibrillator and/or cardioverter AAI or AAI/DDD - Google Patents
Implantable active medical device like a cardiac stimulator, defibrillator and/or cardioverter AAI or AAI/DDD Download PDFInfo
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- EP1470836A1 EP1470836A1 EP04290953A EP04290953A EP1470836A1 EP 1470836 A1 EP1470836 A1 EP 1470836A1 EP 04290953 A EP04290953 A EP 04290953A EP 04290953 A EP04290953 A EP 04290953A EP 1470836 A1 EP1470836 A1 EP 1470836A1
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- 206010047289 Ventricular extrasystoles Diseases 0.000 claims description 7
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
- A61N1/3622—Heart stimulators for treating or preventing abnormally high heart rate comprising two or more electrodes co-operating with different heart regions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
- A61N1/3962—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
- A61N1/39622—Pacing therapy
Definitions
- the invention relates to "active implantable medical devices" such as defined by Council of the European Communities Directive 90/385 / EEC of 20 June 1990 Europeans, specifically pacemaker devices, "multisite” devices (triple or quadruple chamber), defibrillators and / or cardiovertors, allowing to deliver at the heart of the pulses low energy electrodes for the treatment of rhythm disorders heart.
- active implantable medical devices such as defined by Council of the European Communities Directive 90/385 / EEC of 20 June 1990 Europeans, specifically pacemaker devices, "multisite” devices (triple or quadruple chamber), defibrillators and / or cardiovertors, allowing to deliver at the heart of the pulses low energy electrodes for the treatment of rhythm disorders heart.
- DDD stimulation and detection circuits on both the atrium and on the ventricle and can operate according to two modes of operation, DDD or AAI (the AAI mode is actually a DDD mode including a delay atrioventricular lengthened).
- DDD-CAM automatic switching of the mode (CAM) from DDD to AAI and vice versa.
- the invention is not limited to these devices automatically switch mode, but can apply devices operating in AAI mode alone, in so far as, in certain configurations, the invention proposes only to arrange the functioning of the AAI mode, without automatic switching of mode and / or to avoid automatic mode switching.
- the basic operating mode of a DDD / AAI stimulator is a AAI mode, with single-chamber atrial pacing and surveillance (detection) of ventricular activity. This mode is maintained as long as atrio-ventricular conduction is normal, that is, as long as each atrial event (atrial sensing, corresponding to an activity spontaneous, or atrial pacing) is followed by ventricular sensing associated.
- blocks may appear Atrio-ventricular (AVB) resulting in a temporary defect of depolarization of the ventricle.
- the stimulator switches automatically in automatic DDD mode, with parameters optimized for this temporary BAV situation. After the disappearance of the BAV, and thus recovery spontaneous atrio-ventricular conduction, since a certain number of conditions are met the stimulator automatically returns in AAI mode.
- the starting point of the invention lies in a number of observations performed during a clinical follow-up of patients paired with AAI or DDD / AAI devices with automatic mode switching, when these patients have ventricular extrasystoles (VAS).
- VAS ventricular extrasystoles
- ESVs are spontaneous ventricular events that are not preceded by atrial depolarization and have shortening significant of the RR (or VR) interval with respect to the event previous ventricular.
- the ESV can occur either simultaneously with the depolarization auricular of the next beat, ie at a time close to the end of the interval atrial escape (IEA), that is to say at the moment when a stimulation ear must be delivered in the absence of a spontaneous event detected in the atrium.
- IEEEA interval atrial escape
- the known devices have limitations in their ability to correctly detect or manage activity Cardiac electrical therapy in case of ESV occurrence at certain critical moments of the heart wave.
- the means suitable for modify at least one operating parameter of the device can including resetting the count of the atrial escape interval on detection of ventricular extrasystole (VES).
- VES ventricular extrasystole
- the invention applies very advantageously to devices of the "DDD-CAM" type above, that is to say comprising: ventricular pacing means ; Atrio-ventricular block diagnostic means capable of detect the appearance and repetition of spontaneous atrial events or stimulated, not followed by the detection of a spontaneous ventricular event partner; mode switching means, able to control switching from an AAI mode to a DDD mode in case of diagnosis proven to have atrio-ventricular block; characterized in that said means capable of modifying at least one operating parameter of the device are means capable of inhibiting said switching means fashion.
- the means capable to change at least one operating parameter of the device can then in particular: in case of occurrence of a ventricular extrasystole, measure the time between the last detected atrial event and the moment of onset of this ventricular extrasystole; position an indicator of suspicion of false diagnosis if (i) the time frame measured is within a predetermined time interval, less than the duration of the atrial escape interval as assessed by means of atrial pacing, and / or if (ii) stimulation ventricular is delivered inside a safety window following the delivery of atrial pacing; detect and count stimulations not followed by an associated spontaneous ventricular event ; and inhibit mode switching for a first number of predetermined cycles, for example twelve cycles, if (i) at least one stimulation auricular not followed by an associated spontaneous ventricular event has been detected and (ii) the indicator of suspicion of false diagnosis is the state positioned.
- Said predetermined time interval is for example a lower interval from 63 ms to the duration of the atrial escape interval.
- the indicator of suspicion of false diagnosis can be restored to its initial state if no atrial pacing is not followed by a ventricular event associated spontaneous was detected during a second number of predetermined cycles, for example twelve cycles.
- the means capable of modifying at least one operating parameter of the device may include: if an extrasystole occurs ventricular, measure the time between the last event ear detected and the time of onset of this ventricular extrasystole ; and extend the atrial escape interval by a predetermined duration if (i) the time thus measured is within a predetermined time interval, less than the duration of the escape interval auricular as initially assessed by means of atrial pacing, and / or if (ii) ventricular pacing is delivered inside a security window following the delivery of a stimulation Atrial.
- Said predetermined duration of extension of the escape interval auricular is for example 63 ms.
- the atrial escape interval can be restored to its initial value if no atrial pacing is not followed by a ventricular event associated spontaneous response has been detected for a predetermined number of cycles, for example twelve cycles.
- Figure 1a illustrates a first case where the occurrence of a PVC in one period criticism induces an improper operation, for a the prior art.
- Figure 1b illustrates the same situation as Figure 1a, showing the way whose invention avoids this inappropriate operation.
- FIGS. 2a and 2b are homologous to FIGS. 1a and 1b, for a second case of VVM at critical time.
- Figure 3 illustrates a third case of occurrence of a VES in period critical, for a device of the prior art.
- Figure 4 illustrates a fourth case of occurrence of an ESV in period critical, for a device of the prior art.
- Fig. 5 is a flowchart illustrating a diagnostic algorithm of BAV type II, adapted according to the invention to suspend the treatment of this BAV II in case of detection of a false positive resulting from the occurrence ESV in a critical period.
- the invention can be implemented by appropriate programming of the control software of a known stimulator of the double chamber type integrating DDD mode and AAI mode with activity monitoring ventricular.
- the invention can also be applied to pacemakers operating only in AAI mode, by conditions of implementation of this mode.
- Detection P collection of spontaneous activity originating in the atrium; it will be considered that there is indeed P detection if it is not followed within a given time, for example within 31 ms, by a ventricular detection (otherwise, one would be in a situation of " ventricular far-field" ", that is to say, collection via the atrium of a distant depolarization from the ventricle).
- Detection R collection of a spontaneous activity having its origin in the ventricle.
- Stimulation A stimulation delivered to the atrium.
- Stimulation V stimulation delivered to the ventricle.
- Ear event P detection or A stimulation.
- Ventricular event R detection or V stimulation.
- Cardiac cycle time interval separating two events of the same nature in the same cavity, for example separating two detection P, or two stimulations A.
- Mean PP mean interval of the atrial rhythm, calculated for example on eight cardiac cycles not including extrasystole.
- Atrial Escape Interval (IEA) The interval of time, counted after a detection or stimulation in the atrium, after which a stimulation is delivered to this atrium if no spontaneous event has been detected in this same cavity .
- Ventricular Extrasystole A Ventricular Detection is a VSC when it is preceded by ventricular sensing or pacing, and when the coupling interval (RR or VR interval) is less than or equal to a parameterizable value, for example 75% of the average PP.
- EP-A-0 550 342 (Ela Medical).
- the operation of the stimulator is an operation in AAI mode with monitoring of ventricular activity, that is, atrial detection outside refractory period (P detection) or stimulation auricular (A stimulation) do not start VAD, but start an atrial escape interval IEA.
- P detection atrial detection outside refractory period
- a stimulation stimulation auricular
- the AAI mode being provided with a ventricular activity monitoring, the algorithm also looks for the presence or absence of an activity ventricular, which in the latter case could lead to suspicion of an AVB, in order to possibly switch to DDD dual stimulation mode room with atrio-ventricular association, that is to say with calculation and application of a DAV.
- the device switches from the AAI mode to DDD mode.
- the device After return of spontaneous ventricular activity on a number of cycles, or after a predetermined number of cycles in DDD mode, the device then switches from DDD to AAI and remains in AAI mode none of the three aforementioned AAI to DDD switching criteria is not checked.
- the device considers that there has been no P wave and therefore, according to the operating mode AAI, do not recycle the IEA (the pure AAI mode being a mode without detection of ventricular activity).
- the pacemaker delivers atrial pacing at the end of the escape interval IEA, inducing atrial depolarization A1.
- this depolarization stimulated atrial A1 will be premature, with the risk of inducing a disorder of the atrial rhythm if it occurs during the period of vulnerability of the atrium.
- the solution proposed by the invention, illustrated in FIG. 1b, is to recycle the IEA on detection of an ESV.
- the recycling of the IEA on this event ventricular will have the same effect as if it had been generated by an event spontaneous auricular.
- the new IEA * interval will have the effect of delaying in time the delivery of the atrial pacing pulse in the absence of spontaneous depolarization (wave A1 * in Figure 1b).
- the maximum error introduced by recycling the IEA on the ventricular event ESV corresponds to the case where the spontaneous event auricular occurs at the end of post-VES refractory period, which physiologically is perfectly acceptable (ie the maximum delay stimulation is equal to the duration of this refractory period).
- the second case, illustrated in FIG. 2a, is that in which the atrial depolarization P2 intervenes not earlier, but shortly after the detection of the ESV.
- the atrial depolarization is not detected by the device, because it occurs during the post-ventricular atrial refractory period (PVARP).
- PVARP post-ventricular atrial refractory period
- the IEA is not not recycled and atrial stimulation is delivered at the end of IEA, inducing an atrial atrial depolarization A1.
- This atrial stimulation A1 is more premature than the depolarization hidden atrial P2, it may be ineffective, that is, not induce associated ventricular depolarization by the natural pathways of conduction.
- the stimulator thus detects a configuration with stimulation auricular not followed by ventricular depolarization, that is, a BAV situation. If this sequence is repeated more than three times on twelve, the device automatically switches to DDD mode, so perfectly inappropriate.
- this case is likely to have two disadvantages, both hemodynamic (as in the first case) because of of an atrial pacing occurring at an inappropriate time but also an error diagnosis of BAV causing a switch untimely mode if this diagnosis is repeated.
- the solution proposed by the invention consists, as in the first case, to recycle the IEA on VSE detection, as shown in Figure 2b: IEA is recycled to IEA *, inducing depolarization-inducing stimulation auricular A1 * respecting the natural rhythm of the patient (therefore satisfactory hemodynamically) and to induce in turn a ventricular depolarization (therefore without detection of BAV) with a temporal error on the moment of delivery of this stimulation which remains within physiologically acceptable limits.
- Atrial pacing (A1 *) can no longer be delivered prematurely after ESV and depolarize the ventricle by natural ways of atrioventricular conduction, which are again excitable.
- the third case, illustrated in FIG. 3, is that, in the absence of spontaneous atrial depolarization, stimulation occurs at the end of the escape interval IEA with application of a concomitant VES to the V1 safety stimulation. (see below).
- Aural stimulation A1 at the end of the IEA will trigger the counting of a so-called atrioventricular cross-talk monitoring period (PSCTAV), which is a window defined typically by an interval [50 ms, 94 ms] following the stimulation. auricular A1.
- PSCTAV atrioventricular cross-talk monitoring period
- the device is unable to differentiate between a true depolarization ventricular (in this case ESV), and detection in the ventricle a signal that would actually come from the auricular electrical stimulus. Because of this uncertainty, as a precaution, the device delivers a stimulation safety ventricular V1, typically 100 ms after stimulation auricular A1. This case does not induce an erroneous BAV diagnosis; however it is not a correct AAI behavior because in AAI mode should not normally be in any way influenced by ventricular activity - which is not the case here, so with the consequential disadvantages on the hemodynamic level.
- ESV true depolarization ventricular
- the fourth case, illustrated in Figure 4, is one where, as in the previous case, the end of the AEI occurs a few milliseconds before the ESV, ESV but here occurring in the period of post-pace blanking atrial (PBPSA) .
- PBPSA post-pace blanking atrial
- the ESV is not even detected (the blanking is to temporarily block any detection of the signal after stimulation, so as to avoid saturating the amplifier stages) .
- Atrial A1 stimulation is triggered at the end of IEA can not induce ventricular depolarization conduct, because the ESV momentarily renders the conduction tissues refractory.
- the device considers that the wave A1 is an auricular wave blocked and recycles a new IEA interval by indicating a diagnosis of BAV; this diagnosis is actually a false positive, because the absence of depolarization ventricular driving is only due to the fact that an ESV has occurred meanwhile, and not at the appearance of a constituent conduction defect a BAV.
- the invention proposes two techniques applicable to solve the problems that we have just exposed related to the third case and the fourth case (and incidentally in the second case above, too).
- the first technique is, when a probable diagnosis of BAV II, to analyze the circumstances that led to this diagnosis of BAV to determine if it is a true BAV II or a false diagnosis due to a configuration corresponding to one of the aforementioned cases and, if so, to suspend the treatment of BAV II by inhibiting any undesirable passage in DDD mode.
- C1 and C2 will be designated two particular counters implemented by this flowchart.
- the counter C1 is a counter initialized for example at 12 (corresponding in this case to the numerator of the ratio 12/9 between the number of waves Non-extrasystolic P and the non-extrasystolic R wave count used for the diagnosis of BAV II as explained above). Initialization of this counter is performed when a suspicious ESV is detected, occurring at the end of IEA and corresponding to the case indicated above of stimulation in the security window, or in the case of an ESV whose coupling is such that it occurs at the same time as the end of the IEA.
- This counter C1 is decremented by one unit at each ventricular event associated with an atrial event or each ESV whose interval The coupling time is significantly different from that of IEA.
- the counter C2 for its part, is for example initialized to 12 (given value for example, defined in the same way as for the counter C1), this initialization occurring when the algorithm detects is a stimulation in a security window, ie an ESV occurring at the end of the IEA, and a blocked atrial pacing has been analyzed in the last 12 cycles.
- This counter C2 is decremented by one unit on any ventricular event.
- the device measures the interval between the last wave P and the occurrence of this ESV (interval [P, ESV]). If this interval is close to the duration of the IEA, typically if one has: IEA-63 ms ⁇ [P, ESV] ⁇ IEA, then an indicator of suspicion of false diagnosis is set to '1' (flag spotted "flag suspicion false diag" on the flowchart of Figure 5). During a safety window stimulation, this suspicion indicator is also set to '1'.
- the device does not find any ESV of duration close to the IEA (in the sense indicated above) or no stimulation in safety windows, and no blocked atrial pacing is not detected during, for example, twelve cycles, then the indicator of suspicion of false diagnosis is given to zero, as well as the counter C2.
- a second technique consists in detecting an ESV close to the end of the IEA (in the sense indicated above for the first technique), or in a safety window stimulation, to prolong the interval of IEA escape, for example of a duration of 63 ms. Extending the escape interval avoids any conflict between proper detection of the ESV and satisfactory AAI behavior.
- This prolongation will continue for a given time, for example during twelve cycles, unless one of the two events above is again detected by the device.
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Abstract
Description
L'invention concerne les "dispositifs médicaux implantables actifs" tels que définis par la directive 90/385/CEE du 20 juin 1990 du Conseil des communautés européennes, plus précisément les dispositifs stimulateurs cardiaques, dispositifs "multisite" (triple ou quadruple chambre), défibrillateurs et/ou cardioverteurs, permettant de délivrer au coeur des impulsions électriques de faible énergie pour le traitement des troubles du rythme cardiaque.The invention relates to "active implantable medical devices" such as defined by Council of the European Communities Directive 90/385 / EEC of 20 June 1990 Europeans, specifically pacemaker devices, "multisite" devices (triple or quadruple chamber), defibrillators and / or cardiovertors, allowing to deliver at the heart of the pulses low energy electrodes for the treatment of rhythm disorders heart.
Elle concerne plus particulièrement ceux de ces dispositifs qui comprennent des circuits de stimulation et de détection à la fois sur l'oreillette et sur le ventricule et peuvent opérer selon deux modes de fonctionnement, DDD ou AAI (le mode AAI étant en fait un mode DDD comprenant un délai atrio-ventriculaire allongé). Ces dispositifs peuvent être pourvus d'un mode dénommé "DDD-CAM" assurant une commutation automatique du mode (CAM) de DDD en AAI et inversement.It relates more particularly to those devices that include stimulation and detection circuits on both the atrium and on the ventricle and can operate according to two modes of operation, DDD or AAI (the AAI mode is actually a DDD mode including a delay atrioventricular lengthened). These devices may be provided with a referred to as "DDD-CAM" providing automatic switching of the mode (CAM) from DDD to AAI and vice versa.
Toutefois, comme on le verra par la suite, l'invention n'est pas limitée à ces dispositifs à commutation automatique de mode, mais peut s'appliquer à des dispositifs opérant en mode AAI seul, dans la mesure où, dans certaines configurations, l'invention propose seulement d'aménager le fonctionnement du mode AAI, sans qu'il y ait commutation automatique de mode et/ou pour éviter une commutation automatique de mode.However, as will be seen later, the invention is not limited to these devices automatically switch mode, but can apply devices operating in AAI mode alone, in so far as, in certain configurations, the invention proposes only to arrange the functioning of the AAI mode, without automatic switching of mode and / or to avoid automatic mode switching.
Le mode de fonctionnement de base d'un stimulateur DDD/AAI est un mode AAI, avec une stimulation auriculaire simple chambre et une surveillance (détection) de l'activité ventriculaire. Ce mode est maintenu tant que la conduction atrio-ventriculaire est normale, c'est-à-dire tant que chaque événement auriculaire (détection auriculaire, correspondant à une activité spontanée, ou stimulation auriculaire) est suivi d'une détection ventriculaire associée.The basic operating mode of a DDD / AAI stimulator is a AAI mode, with single-chamber atrial pacing and surveillance (detection) of ventricular activity. This mode is maintained as long as atrio-ventricular conduction is normal, that is, as long as each atrial event (atrial sensing, corresponding to an activity spontaneous, or atrial pacing) is followed by ventricular sensing associated.
Dans certaines circonstances peuvent cependant apparaítre des blocs atrio-ventriculaires (BAV) entraínant un défaut temporaire de dépolarisation du ventricule. Dans ce cas, le stimulateur bascule automatiquement en mode DDD automatique, avec des paramètres optimisés pour cette situation de BAV temporaire. Après disparition du BAV, et donc rétablissement de la conduction atrio-ventriculaire spontanée, dès lors qu'un certain nombre de conditions sont remplies le stimulateur retourne automatiquement au mode AAI. In certain circumstances, however, blocks may appear Atrio-ventricular (AVB) resulting in a temporary defect of depolarization of the ventricle. In this case, the stimulator switches automatically in automatic DDD mode, with parameters optimized for this temporary BAV situation. After the disappearance of the BAV, and thus recovery spontaneous atrio-ventricular conduction, since a certain number of conditions are met the stimulator automatically returns in AAI mode.
Cette commutation des modes DDD et AAI est par exemple décrite dans le EP-A-0 488 904 (ELA Médical).This switching of the DDD and AAI modes is for example described in EP-A-0 488 904 (Medical ELA).
Le point de départ de l'invention réside dans un certain nombre d'observations effectuées lors d'un suivi clinique de patients appareillés avec des dispositifs AAI ou DDD/AAI à commutation automatique de mode, lorsque ces patients présentent des extrasystoles ventriculaires (ESV).The starting point of the invention lies in a number of observations performed during a clinical follow-up of patients paired with AAI or DDD / AAI devices with automatic mode switching, when these patients have ventricular extrasystoles (VAS).
Les ESV sont des événements ventriculaires spontanés qui ne sont pas précédés d'une dépolarisation auriculaire et qui présentent un raccourcissement significatif de l'intervalle RR (ou VR) par rapport à l'événement ventriculaire précédent.ESVs are spontaneous ventricular events that are not preceded by atrial depolarization and have shortening significant of the RR (or VR) interval with respect to the event previous ventricular.
Selon le couplage de ces ESV par rapport à l'événement ventriculaire précédent, l'ESV peut survenir soit simultanément avec la dépolarisation auriculaire du battement suivant, soit à un instant proche de la fin de l'intervalle d'échappement auriculaire (IEA), c'est-à-dire à l'instant où une stimulation auriculaire doit être délivrée en l'absence d'événement spontané détecté dans l'oreillette.According to the coupling of these ESVs with respect to the ventricular event previous, the ESV can occur either simultaneously with the depolarization auricular of the next beat, ie at a time close to the end of the interval atrial escape (IEA), that is to say at the moment when a stimulation ear must be delivered in the absence of a spontaneous event detected in the atrium.
On constate ainsi que, dans un certain nombre de situations qui seront décrites plus en détail par la suite, les appareils connus présentent des limites dans leur capacité à détecter ou à gérer correctement l'activité électrique cardiaque en cas de survenue d'ESV à certains instants critiques de l'onde cardiaque.Thus, in a number of situations that will be described in more detail later, the known devices have limitations in their ability to correctly detect or manage activity Cardiac electrical therapy in case of ESV occurrence at certain critical moments of the heart wave.
Cette incapacité à gérer correctement toutes les situations susceptibles de se présenter en cas de survenue d'ESV a pour effet :
- soit de délivrer au coeur des stimulations auriculaires ou ventriculaires inappropriées, donc inefficaces - voire dangereuses - sur le plan hémodynamique,
- soit, avec les dispositifs AAI/DDD à commutation automatique de mode, de provoquer des basculements intempestifs vers le mode DDD du fait d'un faux diagnostic de bloc auriculo-ventriculaire (le dispositif croit détecter l'apparition d'un BAV, alors qu'en réalité la conduction spontanée est présente),
- soit un cumul des deux actions erronées, c'est-à-dire stimulation inappropriée suivie d'un basculement inutile en mode DDD.
- to deliver at the heart of atrial or ventricular stimulations inappropriate, therefore ineffective - even dangerous - on the hemodynamic level,
- or, with AAI / DDD devices automatically switching mode, to cause inadvertent switchover to DDD mode due to a false diagnosis of atrioventricular block (the device believes detect the appearance of a BAV, while in fact spontaneous conduction is present),
- either a combination of the two erroneous actions, that is to say inappropriate stimulation followed by a useless switchover in DDD mode.
Ces actions inappropriées peuvent créer chez certains patients vulnérables des conditions propices à l'apparition de troubles du rythme ventriculaire, qu'il est important de pouvoir prévenir.These inappropriate actions can create in some vulnerable patients conditions conducive to the onset of ventricular arrhythmias, that it is important to be able to prevent.
À cet effet, le dispositif de l'invention propose un dispositif médical implantable actif tel que stimulateur cardiaque, défibrillateur et/ou cardioverteur, comprenant :
- des moyens de détection d'événements auriculaires et ventriculaires spontanés, incluant des moyens aptes à détecter la survenue d'extrasystoles ventriculaires parmi les événements ventriculaires spontanés,
- des moyens de stimulation auriculaire, incluant des moyens aptes à calculer un intervalle d'échappement auriculaire et déclencher le comptage de cet intervalle d'échappement auriculaire sur détection d'un événement auriculaire, et à délivrer une stimulation auriculaire à la fin de l'intervalle d'échappement auriculaire si aucun événement auriculaire spontané n'a été détecté dans l'intervalle,
- means for detecting spontaneous atrial and ventricular events, including means capable of detecting the occurrence of ventricular extrasystoles among the spontaneous ventricular events,
- atrial pacing means, including means for calculating an atrial escape interval and triggering the counting of this atrial escape interval upon detection of an atrial event, and delivering atrial pacing at the end of the interval atrial escape if no spontaneous atrial event has been detected in the meantime,
Selon l'invention, ce dispositif comprend en outre :
- des moyens aptes à définir une période critique précédant ou suivant la fin de l'intervalle d'échappement auriculaire telle qu'évaluée par les moyens de stimulation auriculaire,
- des moyens aptes à déterminer, en cas de détection d'une extrasystole ventriculaire, si l'instant de survenue de cette extrasystole ventriculaire se situe dans ladite période critique, de manière à reconnaítre ainsi l'apparition d'une condition de risque de fonctionnement inapproprié et/ou de faux diagnostic du dispositif liée à la proximité temporelle de l'extrasystole ventriculaire et de la fin de l'intervalle d'échappement auriculaire, et
- des moyens aptes, dans l'affirmative, à modifier au moins un paramètre de fonctionnement du dispositif de manière à éliminer ladite condition de risque et/ou de faux diagnostic.
- means capable of defining a critical period preceding or following the end of the atrial escape interval as evaluated by the atrial stimulating means,
- means capable of determining, in the event of detection of a ventricular extrasystole, whether the moment of occurrence of this ventricular extrasystole is in said critical period, so as to recognize the occurrence of a condition of risk of inappropriate operation and / or false diagnosis of the device related to the temporal proximity of the ventricular extrasystole and the end of the atrial escape interval, and
- means adapted, if so, to modify at least one operating parameter of the device so as to eliminate said risk condition and / or false diagnosis.
Ladite période critique peut être :
- une période définie par une fenêtre temporelle précédant la fin de l'intervalle d'échappement auriculaire d'une durée prédéterminée, par exemple précédant de moins de 63 ms la fin de l'intervalle d'échappement auriculaire ;
- une période réfractaire auriculaire post-ventriculaire suivant la fin de l'intervalle d'échappement auriculaire et dont le comptage est déclenché sur détection de l'extrasystole ventriculaire ;
- une période de surveillance de cross-talk auriculo-ventriculaire suivant la fin de l'intervalle d'échappement auriculaire et dont le comptage est déclenché sur délivrance d'une impulsion de stimulation auriculaire à la fin de l'intervalle d'échappement auriculaire ;
- une période de blanking post-stimulation auriculaire suivant la fin de l'intervalle d'échappement auriculaire et dont le comptage est déclenché sur délivrance d'une impulsion de stimulation auriculaire à la fin de l'intervalle d'échappement auriculaire.
- a period defined by a time window preceding the end of the atrial escape interval of a predetermined duration, for example preceding by less than 63 ms the end of the atrial escape interval;
- a post-ventricular atrial refractory period following the end of the atrial escape interval and whose counting is triggered on detection of the ventricular extrasystole;
- an atrioventricular cross-talk monitoring period following the end of the atrial escape interval and whose count is triggered upon delivery of an atrial pacing pulse at the end of the atrial escape interval;
- an atrial post-stimulation blanking period following the end of the atrial escape interval and whose count is triggered upon delivery of an atrial pacing pulse at the end of the atrial escape interval.
Pour les premier et deuxième cas de période critique, les moyens aptes à modifier au moins un paramètre de fonctionnement du dispositif peuvent notamment réinitialiser le comptage de l'intervalle d'échappement auriculaire sur détection de l'extrasystole ventriculaire (ESV).For the first and second critical period cases, the means suitable for modify at least one operating parameter of the device can including resetting the count of the atrial escape interval on detection of ventricular extrasystole (VES).
L'invention s'applique très avantageusement aux dispositifs de type "DDD-CAM" précités, c'est-à-dire comprenant : des moyens de stimulation ventriculaire ; des moyens de diagnostic de bloc atrio-ventriculaire, aptes à détecter l'apparition et la répétition d'événements auriculaires, spontanés ou stimulés, non suivis de la détection d'un événement ventriculaire spontané associé ; des moyens de commutation de mode, aptes à commander le basculement d'un mode AAI en un mode DDD en cas de diagnostic avéré d'un bloc atrio-ventriculaire ; dispositif caractérisé en ce que lesdits moyens aptes à modifier au moins un paramètre de fonctionnement du dispositif sont des moyens aptes à inhiber lesdits moyens de commutation de mode.The invention applies very advantageously to devices of the "DDD-CAM" type above, that is to say comprising: ventricular pacing means ; Atrio-ventricular block diagnostic means capable of detect the appearance and repetition of spontaneous atrial events or stimulated, not followed by the detection of a spontaneous ventricular event partner; mode switching means, able to control switching from an AAI mode to a DDD mode in case of diagnosis proven to have atrio-ventricular block; characterized in that said means capable of modifying at least one operating parameter of the device are means capable of inhibiting said switching means fashion.
Pour les deuxième et quatrième cas de période critique, les moyens aptes à modifier au moins un paramètre de fonctionnement du dispositif peuvent alors notamment : en cas de survenue d'une extrasystole ventriculaire, mesurer le laps de temps séparant le dernier événement auriculaire détecté et l'instant de survenue de cette extrasystole ventriculaire ; positionner un indicateur de suspicion de faux diagnostic si (i) le laps de temps ainsi mesuré se situe à l'intérieur d'un intervalle de temps prédéterminé, inférieur à la durée de l'intervalle d'échappement auriculaire telle qu'évaluée par les moyens de stimulation auriculaire, et/ou si (ii) une stimulation ventriculaire est délivrée à l'intérieur d'une fenêtre de sécurité suivant la délivrance d'une stimulation auriculaire ; détecter et compter les stimulations auriculaires non suivies d'un événement ventriculaire spontané associé ; et inhiber la commutation de mode pendant un premier nombre de cycles prédéterminé, par exemple douze cycles, si (i) au moins une stimulation auriculaire non suivie d'un événement ventriculaire spontané associé a été détectée et (ii) l'indicateur de suspicion de faux diagnostic est à l'état positionné.For the second and fourth cases of critical period, the means capable to change at least one operating parameter of the device can then in particular: in case of occurrence of a ventricular extrasystole, measure the time between the last detected atrial event and the moment of onset of this ventricular extrasystole; position an indicator of suspicion of false diagnosis if (i) the time frame measured is within a predetermined time interval, less than the duration of the atrial escape interval as assessed by means of atrial pacing, and / or if (ii) stimulation ventricular is delivered inside a safety window following the delivery of atrial pacing; detect and count stimulations not followed by an associated spontaneous ventricular event ; and inhibit mode switching for a first number of predetermined cycles, for example twelve cycles, if (i) at least one stimulation auricular not followed by an associated spontaneous ventricular event has been detected and (ii) the indicator of suspicion of false diagnosis is the state positioned.
Ledit intervalle de temps prédéterminé est par exemple un intervalle inférieur de 63 ms à la durée de l'intervalle d'échappement auriculaire.Said predetermined time interval is for example a lower interval from 63 ms to the duration of the atrial escape interval.
L'indicateur de suspicion de faux diagnostic peut être rétabli à son état initial si aucune stimulation auriculaire non suivie d'un événement ventriculaire spontané associé n'a été détectée pendant un second nombre de cycles prédéterminé, par exemple douze cycles.The indicator of suspicion of false diagnosis can be restored to its initial state if no atrial pacing is not followed by a ventricular event associated spontaneous was detected during a second number of predetermined cycles, for example twelve cycles.
Pour les deuxième, troisième et quatrième cas de période critique, les moyens aptes à modifier au moins un paramètre de fonctionnement du dispositif peuvent notamment : en cas de survenue d'une extrasystole ventriculaire, mesurer le laps de temps séparant le dernier événement auriculaire détecté et l'instant de survenue de cette extrasystole ventriculaire ; et prolonger l'intervalle d'échappement auriculaire d'une durée prédéterminée si (i) le laps de temps ainsi mesuré se situe à l'intérieur d'un intervalle de temps prédéterminé, inférieur à la durée de l'intervalle d'échappement auriculaire telle qu'initialement évaluée par les moyens de stimulation auriculaire, et/ou si (ii) une stimulation ventriculaire est délivrée à l'intérieur d'une fenêtre de sécurité suivant la délivrance d'une stimulation auriculaire.For the second, third and fourth critical period cases, the means capable of modifying at least one operating parameter of the device may include: if an extrasystole occurs ventricular, measure the time between the last event ear detected and the time of onset of this ventricular extrasystole ; and extend the atrial escape interval by a predetermined duration if (i) the time thus measured is within a predetermined time interval, less than the duration of the escape interval auricular as initially assessed by means of atrial pacing, and / or if (ii) ventricular pacing is delivered inside a security window following the delivery of a stimulation Atrial.
Ladite durée prédéterminée de prolongation de l'intervalle d'échappement auriculaire est par exemple de 63 ms.Said predetermined duration of extension of the escape interval auricular is for example 63 ms.
L'intervalle d'échappement auriculaire peut être rétabli à sa valeur initiale si aucune stimulation auriculaire non suivie d'un événement ventriculaire spontané associé n'a été détectée pendant un nombre de cycles prédéterminé, par exemple douze cycles.The atrial escape interval can be restored to its initial value if no atrial pacing is not followed by a ventricular event associated spontaneous response has been detected for a predetermined number of cycles, for example twelve cycles.
On va maintenant décrire un exemple de mise en oeuvre du dispositif de l'invention, en référence aux dessins annexés.We will now describe an example of implementation of the device of the invention, with reference to the accompanying drawings.
La figure 1a illustre un premier cas où la survenue d'une ESV en une période critique induit un fonctionnement inapproprié, pour un dispositif de l'art antérieur.Figure 1a illustrates a first case where the occurrence of a PVC in one period criticism induces an improper operation, for a the prior art.
La figure 1b illustre la même situation que la figure 1a, en montrant la manière dont l'invention permet d'éviter ce fonctionnement inapproprié.Figure 1b illustrates the same situation as Figure 1a, showing the way whose invention avoids this inappropriate operation.
Les figures 2a et 2b sont homologues des figures 1a et 1b, pour un deuxième cas de survenue d'une ESV en période critique.FIGS. 2a and 2b are homologous to FIGS. 1a and 1b, for a second case of VVM at critical time.
La figure 3 illustre un troisième cas de survenue d'une ESV en période critique, pour un dispositif de l'art antérieur.Figure 3 illustrates a third case of occurrence of a VES in period critical, for a device of the prior art.
La figure 4 illustre un quatrième cas de survenue d'une ESV en période critique, pour un dispositif de l'art antérieur.Figure 4 illustrates a fourth case of occurrence of an ESV in period critical, for a device of the prior art.
La figure 5 est un organigramme illustrant un algorithme de diagnostic de BAV de type II, adapté selon l'invention pour suspendre le traitement de ce BAV II en cas de détection d'un faux positif résultant de la survenue d'une ESV dans une période critique.Fig. 5 is a flowchart illustrating a diagnostic algorithm of BAV type II, adapted according to the invention to suspend the treatment of this BAV II in case of detection of a false positive resulting from the occurrence ESV in a critical period.
L'invention peut être mise en oeuvre par une programmation appropriée du logiciel de commande d'un stimulateur connu de type double chambre intégrant un mode DDD et un mode AAI avec surveillance de l'activité ventriculaire.The invention can be implemented by appropriate programming of the control software of a known stimulator of the double chamber type integrating DDD mode and AAI mode with activity monitoring ventricular.
Toutefois, comme on l'a indiqué plus haut, et comme on le verra par la suite, par certains aspects l'invention peut également s'appliquer à des stimulateurs fonctionnant seulement en mode AAI, par aménagement des conditions de mise en oeuvre de ce mode.However, as indicated above, and as will be seen by the In some respects, the invention can also be applied to pacemakers operating only in AAI mode, by conditions of implementation of this mode.
On va tout d'abord donner un certain nombre de définitions utilisées dans
la suite de la description.
Détection P : recueil d'une activité spontanée ayant son origine
dans l'oreillette ; on considérera qu'il y a effectivement détection P si celle-ci
n'est pas suivie dans un délai donné, par exemple dans les 31 ms, par
une détection ventriculaire (sinon, on se trouverait dans une situation de
"far-field ventriculaire", c'est-à-dire de recueil via l'oreillette d'une dépolarisation
lointaine provenant du ventricule).
Détection R : recueil d'une activité spontanée ayant son origine
dans le ventricule.
Stimulation A : stimulation délivrée à l'oreillette.
Stimulation V: stimulation délivrée au ventricule.
Événement auriculaire : détection P ou bien stimulation A.
Événement ventriculaire : détection R ou bien stimulation V.
Cycle cardiaque : intervalle de temps séparant deux événements
de même nature dans la même cavité, par exemple séparant deux détection
P, ou deux stimulations A.
PP moyen : intervalle moyen du rythme auriculaire, calculé par
exemple sur huit cycle cardiaques ne comprenant pas d'extrasystole.
Intervalle d'échappement auriculaire (IEA) : intervalle de temps,
compté après une détection ou une stimulation dans l'oreillette, à l'issue
duquel une stimulation est délivrée à cette oreillette si aucun événement
spontané n'a été détecté dans cette même cavité.
Extrasystole ventriculaire (ESV) : une détection ventriculaire est
une ESV lorsqu'elle est précédée d'une détection ou d'une stimulation
ventriculaire, et lorsque l'intervalle de couplage (intervalle RR ou VR) est
inférieur ou égal à une valeur paramétrable, par exemple 75 % du PP
moyen.We will first give a number of definitions used in the following description.
Detection P : collection of spontaneous activity originating in the atrium; it will be considered that there is indeed P detection if it is not followed within a given time, for example within 31 ms, by a ventricular detection (otherwise, one would be in a situation of " ventricular far-field" ", that is to say, collection via the atrium of a distant depolarization from the ventricle).
Detection R : collection of a spontaneous activity having its origin in the ventricle.
Stimulation A : stimulation delivered to the atrium.
Stimulation V: stimulation delivered to the ventricle.
Ear event : P detection or A stimulation.
Ventricular event : R detection or V stimulation.
Cardiac cycle : time interval separating two events of the same nature in the same cavity, for example separating two detection P, or two stimulations A.
Mean PP : mean interval of the atrial rhythm, calculated for example on eight cardiac cycles not including extrasystole.
Atrial Escape Interval (IEA) : The interval of time, counted after a detection or stimulation in the atrium, after which a stimulation is delivered to this atrium if no spontaneous event has been detected in this same cavity .
Ventricular Extrasystole (VES) : A Ventricular Detection is a VSC when it is preceded by ventricular sensing or pacing, and when the coupling interval (RR or VR interval) is less than or equal to a parameterizable value, for example 75% of the average PP.
Pour de plus amples détails sur la détection et le traitement des extrasystoles, on pourra se référer au EP-A-0 550 342 (Ela Médical).For more details on the detection and treatment of extrasystoles, we can refer to EP-A-0 550 342 (Ela Medical).
On va maintenant exposer la manière dont est mise en oeuvre l'invention. Au départ, le fonctionnement du stimulateur est un fonctionnement en mode AAI avec surveillance de l'activité ventriculaire, c'est-à-dire qu'une détection auriculaire hors période réfractaire (détection P) ou une stimulation auriculaire (stimulation A) ne démarrent pas de DAV, mais démarrent un intervalle d'échappement auriculaire IEA.We will now explain how the invention is implemented. Initially, the operation of the stimulator is an operation in AAI mode with monitoring of ventricular activity, that is, atrial detection outside refractory period (P detection) or stimulation auricular (A stimulation) do not start VAD, but start an atrial escape interval IEA.
Le mode AAI étant pourvu d'une surveillance de l'activité ventriculaire, l'algorithme recherche par ailleurs la présence ou l'absence d'une activité ventriculaire, qui dans ce dernier cas pourrait laisser suspecter un BAV, de manière à éventuellement basculer en mode DDD de stimulation double chambre avec association atrio-ventriculaire, c'est-à-dire avec calcul et application d'un DAV.The AAI mode being provided with a ventricular activity monitoring, the algorithm also looks for the presence or absence of an activity ventricular, which in the latter case could lead to suspicion of an AVB, in order to possibly switch to DDD dual stimulation mode room with atrio-ventricular association, that is to say with calculation and application of a DAV.
Trois situations peuvent induire le passage au mode DDD :
En présence de l'un de ces critères, le dispositif bascule du mode AAI en mode DDD.In the presence of one of these criteria, the device switches from the AAI mode to DDD mode.
Après retour d'une activité ventriculaire spontanée sur un certain nombre de cycles, ou après un nombre prédéterminé de cycles en mode DDD, le dispositif commute alors de DDD en AAI et demeure en mode AAI tant qu'aucun des trois critères précités de commutation de AAI vers DDD n'est vérifié.After return of spontaneous ventricular activity on a number of cycles, or after a predetermined number of cycles in DDD mode, the device then switches from DDD to AAI and remains in AAI mode none of the three aforementioned AAI to DDD switching criteria is not checked.
Les études cliniques ont révélé cependant plusieurs cas dans lesquels le fonctionnement traditionnel en mode AAI et/ou la commutation AAI/DDD n'opère de manière appropriée, du fait de la survenue d'une ESV à une période critique particulière du rythme cardiaque.However, clinical studies have revealed several cases in which traditional operation in AAI mode and / or AAI / DDD switching does not operate appropriately because of the occurrence of a PVC at a particular critical period of the heart rhythm.
Le premier cas, illustré figure 1a, est celui où la détection auriculaire (onde P2 sur la figure 1a) précède de peu, typiquement de moins de 30 ms, la dépolarisation ventriculaire extrasystolique (ESV). Avec un dispositif connu, cette détection auriculaire P2 sera invalidée par l'algorithme de détection et d'analyse du rythme cardiaque, car le dispositif n'est pas capable de discriminer entre :
- une véritable dépolarisation auriculaire spontanée, et
- une situation de "far-field ventriculaire" dans l'oreillette, c'est-à-dire une détection auriculaire qui ne résulte pas d'une dépolarisation de l'oreillette, mais qui est un signal capté dans l'oreillette provenant de la détection de l'ESV "entendue dans le lointain" avec retard.
- a true spontaneous atrial depolarization, and
- a situation of " ventricular far-field " in the atrium, that is to say an atrial detection which does not result from a depolarization of the atrium, but which is a signal captured in the atrium from the detection of ESV "heard in the distance" with delay.
Dans le doute, le dispositif considère qu'il n'y a pas eu d'onde P et donc, conformément au mode de fonctionnement AAI, ne recycle pas l'IEA (le mode AAI pur étant un mode sans détection de l'activité ventriculaire). A la fin de l'intervalle d'échappement IEA, comme aucune détection auriculaire spontanée n'a été reconnue et validée depuis l'onde P1, le stimulateur délivre une stimulation auriculaire à la fin de l'intervalle d'échappement IEA, induisant une dépolarisation auriculaire A1.In doubt, the device considers that there has been no P wave and therefore, according to the operating mode AAI, do not recycle the IEA (the pure AAI mode being a mode without detection of ventricular activity). AT the end of the IEA escape interval, as no atrial detection spontaneous has been recognized and validated since the P1 wave, the pacemaker delivers atrial pacing at the end of the escape interval IEA, inducing atrial depolarization A1.
Par rapport à la précédente dépolarisation auriculaire spontanée P2 qui a été invalidée par l'algorithme d'analyse du rythme, cette dépolarisation auriculaire stimulée A1 sera prématurée, avec le risque d'induire un trouble du rythme auriculaire si elle survient dans la période de vulnérabilité de l'oreillette.Compared to the previous spontaneous atrial P2 depolarization that has been invalidated by the rhythm analysis algorithm, this depolarization stimulated atrial A1 will be premature, with the risk of inducing a disorder of the atrial rhythm if it occurs during the period of vulnerability of the atrium.
Enfin, même si cette stimulation induit une dépolarisation auriculaire efficace, c'est-à-dire induisant elle-même une dépolarisation ventriculaire (R2 sur la figure 1a), cette dernière sera prématurée par rapport à l'événement ventriculaire précédent, c'est-à-dire l'événement extrasystolique ESV. De telles conditions sont connues pour générer des troubles du rythme ventriculaire.Finally, even if this stimulation induces an effective atrial depolarization, that is, inducing itself a ventricular depolarization (R2 in Figure 1a), the latter will be premature with respect to the event previous ventricular, ie the ESV extrasystolic event. Of Such conditions are known to generate ventricular rhythm disorders.
La solution proposée par l'invention, illustrée figure 1b, consiste à recycler l'IEA sur détection d'une ESV. Le recyclage de l'IEA sur cet événement ventriculaire aura le même effet que s'il avait été généré par un événement auriculaire spontané. Le nouvel intervalle IEA* aura pour effet de retarder dans le temps la délivrance de l'impulsion de stimulation auriculaire en l'absence de dépolarisation spontanée (onde A1* sur la figure 1b).The solution proposed by the invention, illustrated in FIG. 1b, is to recycle the IEA on detection of an ESV. The recycling of the IEA on this event ventricular will have the same effect as if it had been generated by an event spontaneous auricular. The new IEA * interval will have the effect of delaying in time the delivery of the atrial pacing pulse in the absence of spontaneous depolarization (wave A1 * in Figure 1b).
Par rapport à l'onde P2, l'erreur maximale introduite en recyclant l'IEA sur l'événement ventriculaire ESV correspond au cas où l'événement spontané auriculaire survient en fin de période réfractaire post-ESV, ce qui physiologiquement est tout à fait acceptable (c'est-à-dire que le retard maximal de stimulation est égal à la durée de cette période réfractaire).With respect to the P2 wave, the maximum error introduced by recycling the IEA on the ventricular event ESV corresponds to the case where the spontaneous event auricular occurs at the end of post-VES refractory period, which physiologically is perfectly acceptable (ie the maximum delay stimulation is equal to the duration of this refractory period).
Inversement, si l'ESV est fortement prématurée, le recyclage sur cet événement ventriculaire sera sans conséquence, car la dépolarisation auriculaire ultérieure qui surviendra après la fin de la période réfractaire post-ESV recyclera de nouveau l'IEA, correspondant au comportement AAI attendu. Conversely, if ESV is highly premature, recycling on this event ventricular will be inconsequential because the atrial depolarization after the end of the post-ESV refractory period will recycle the IEA again, corresponding to the expected AAI behavior.
Le deuxième cas, illustré figure 2a est celui où la dépolarisation auriculaire P2 intervient non plus peu avant, mais peu après la détection de l'ESV.The second case, illustrated in FIG. 2a, is that in which the atrial depolarization P2 intervenes not earlier, but shortly after the detection of the ESV.
Dans ce cas, la dépolarisation auriculaire n'est pas détectée par l'appareil, car elle survient pendant la période réfractaire auriculaire post-ventriculaire (PRAPV).In this case, the atrial depolarization is not detected by the device, because it occurs during the post-ventricular atrial refractory period (PVARP).
Cette dépolarisation auriculaire P2 n'étant pas prise en compte, l'IEA n'est pas recyclé et une stimulation auriculaire est donc délivrée en fin d'IEA, induisant une dépolarisation auriculaire indésirable A1.This atrial depolarization P2 not being taken into account, the IEA is not not recycled and atrial stimulation is delivered at the end of IEA, inducing an atrial atrial depolarization A1.
Cette stimulation auriculaire A1 étant plus prématurée que la dépolarisation auriculaire cachée P2, elle peut être inefficace, c'est-à-dire ne pas induire de dépolarisation ventriculaire associée par les voies naturelles de la conduction. Le stimulateur détecte donc une configuration avec stimulation auriculaire non suivie de dépolarisation ventriculaire, c'est-à-dire une situation de BAV. Si cette séquence se reproduit plus de trois fois sur douze, le dispositif bascule automatiquement en mode DDD, de façon parfaitement inappropriée.This atrial stimulation A1 is more premature than the depolarization hidden atrial P2, it may be ineffective, that is, not induce associated ventricular depolarization by the natural pathways of conduction. The stimulator thus detects a configuration with stimulation auricular not followed by ventricular depolarization, that is, a BAV situation. If this sequence is repeated more than three times on twelve, the device automatically switches to DDD mode, so perfectly inappropriate.
Comme on le voit, ce cas est susceptible de présenter deux inconvénients, à la fois hémodynamique (comme dans le premier cas) du fait d'une stimulation auriculaire intervenant à un instant inapproprié, mais également une erreur de diagnostic de BAV entraínant une commutation intempestive de mode si ce diagnostic se répète.As we see, this case is likely to have two disadvantages, both hemodynamic (as in the first case) because of of an atrial pacing occurring at an inappropriate time but also an error diagnosis of BAV causing a switch untimely mode if this diagnosis is repeated.
La solution proposée par l'invention consiste, comme dans le premier cas, à recycler l'IEA sur détection de l'ESV, comme illustré sur la figure 2b : l'IEA est recyclé en IEA*, provoquant une stimulation induisant une dépolarisation auriculaire A1* respectant le rythme naturel du patient (donc satisfaisante sur le plan hémodynamique) et permettant d'induire à son tour une dépolarisation ventriculaire (donc sans détection de BAV) avec une erreur temporelle sur l'instant de délivrance de cette stimulation qui reste dans des limites parfaitement acceptables sur le plan physiologique.The solution proposed by the invention consists, as in the first case, to recycle the IEA on VSE detection, as shown in Figure 2b: IEA is recycled to IEA *, inducing depolarization-inducing stimulation auricular A1 * respecting the natural rhythm of the patient (therefore satisfactory hemodynamically) and to induce in turn a ventricular depolarization (therefore without detection of BAV) with a temporal error on the moment of delivery of this stimulation which remains within physiologically acceptable limits.
Le recyclage de l'IEA sur l'ESV aura une seconde conséquence, à savoir que la stimulation auriculaire (A1*) ne pourra plus être délivrée prématurément après l'ESV et dépolarisera le ventricule par les voies naturelles de conduction auriculo-ventriculaires, qui sont de nouveau excitables. The recycling of the IEA on the ESV will have a second consequence, namely that atrial pacing (A1 *) can no longer be delivered prematurely after ESV and depolarize the ventricle by natural ways of atrioventricular conduction, which are again excitable.
Le troisième cas, illustré sur la figure 3, est celui où, en l'absence de dépolarisation auriculaire spontanée, une stimulation intervient à la fin de l'intervalle d'échappement IEA avec application d'une ESV concomitante à la stimulation de sécurité V1 (voir infra). The third case, illustrated in FIG. 3, is that, in the absence of spontaneous atrial depolarization, stimulation occurs at the end of the escape interval IEA with application of a concomitant VES to the V1 safety stimulation. (see below).
La stimulation auriculaire A1 en fin d'IEA va déclencher le comptage d'une période dite de surveillance de cross-talk auriculo-ventriculaire (PSCTAV), qui est une fenêtre définie typiquement par un intervalle [50 ms, 94 ms] suivant la stimulation auriculaire A1.Aural stimulation A1 at the end of the IEA will trigger the counting of a so-called atrioventricular cross-talk monitoring period (PSCTAV), which is a window defined typically by an interval [50 ms, 94 ms] following the stimulation. auricular A1.
Or le dispositif est incapable de différencier entre une véritable dépolarisation ventriculaire (dans le cas présent l'ESV), et la détection dans le ventricule d'un signal qui proviendrait en fait du stimulus électrique auriculaire. Du fait de cette incertitude, par précaution, le dispositif délivre une stimulation ventriculaire de sécurité V1, typiquement 100 ms après la stimulation auriculaire A1. Ce cas n'induit pas de diagnostic de BAV erroné ; cependant il ne s'agit pas d'un comportement AAI correct, car un fonctionnement en mode AAI ne devrait normalement en aucune façon être influencé par l'activité ventriculaire - ce qui n'est pas le cas ici, avec donc les inconvénients corrélatifs sur le plan hémodynamique.But the device is unable to differentiate between a true depolarization ventricular (in this case ESV), and detection in the ventricle a signal that would actually come from the auricular electrical stimulus. Because of this uncertainty, as a precaution, the device delivers a stimulation safety ventricular V1, typically 100 ms after stimulation auricular A1. This case does not induce an erroneous BAV diagnosis; however it is not a correct AAI behavior because in AAI mode should not normally be in any way influenced by ventricular activity - which is not the case here, so with the consequential disadvantages on the hemodynamic level.
Le quatrième cas, illustré figure 4, est celui où, comme dans le cas précédent, la fin de l'IEA survient quelques millisecondes avant l'ESV, mais l'ESV survenant ici dans la période de blanking post-stimulation auriculaire (PBPSA).The fourth case, illustrated in Figure 4, is one where, as in the previous case, the end of the AEI occurs a few milliseconds before the ESV, ESV but here occurring in the period of post-pace blanking atrial (PBPSA) .
A la différence du cas précédent où l'ESV était détectée mais inopérante, ici l'ESV n'est même pas détectée (le blanking consiste à bloquer temporairement toute détection du signal après une stimulation, de manière à éviter de saturer les étages amplificateurs).Unlike the previous case where the ESV was detected but inoperative, here the ESV is not even detected (the blanking is to temporarily block any detection of the signal after stimulation, so as to avoid saturating the amplifier stages) .
L'ESV n'étant pas détectée par l'appareil, la stimulation auriculaire A1 déclenchée en fin d'IEA ne pourra pas induire de dépolarisation ventriculaire conduite, car l'ESV rend momentanément réfractaires les tissus de conduction.As the ESV is not detected by the device, atrial A1 stimulation is triggered at the end of IEA can not induce ventricular depolarization conduct, because the ESV momentarily renders the conduction tissues refractory.
Dès lors, le dispositif considère que l'onde A1 est une onde auriculaire bloquée et recycle un nouvel intervalle IEA en indiquant un diagnostic de BAV ; ce diagnostic est en fait un faux positif, car l'absence de dépolarisation ventriculaire conduite tient seulement au fait qu'une ESV est survenue entre-temps, et non à l'apparition d'un défaut de conduction constitutif d'un BAV.Therefore, the device considers that the wave A1 is an auricular wave blocked and recycles a new IEA interval by indicating a diagnosis of BAV; this diagnosis is actually a false positive, because the absence of depolarization ventricular driving is only due to the fact that an ESV has occurred meanwhile, and not at the appearance of a constituent conduction defect a BAV.
Comme dans le deuxième cas précité, si cette situation se répète plus de trois fois sur douze, le dispositif bascule en mode DDD, de façon inappropriée puisque cette commutation n'est la conséquence d'aucun BAV réel.As in the second case mentioned above, if this situation is repeated more three times out of twelve, the device switches to DDD mode, inappropriately since this switching is the consequence of no real BAV.
Outre le recyclage de l'IEA sur détection de l'ESV, qui permet de résoudre les problèmes liés au premier cas et au deuxième cas précités, l'invention propose deux techniques applicables pour résoudre les problèmes que l'on vient d'exposer liés au troisième cas et au quatrième cas (et accessoirement au deuxième cas précité, aussi).In addition to recycling the IEA on detection of ESV, which solves the problems related to the first case and the second case mentioned above, the invention proposes two techniques applicable to solve the problems that we have just exposed related to the third case and the fourth case (and incidentally in the second case above, too).
La première technique, illustrée par l'organigramme de la figure 5, consiste, lors d'un probable diagnostic de BAV II, à analyser les circonstances ayant conduit à ce diagnostic de BAV de manière à déterminer s'il s'agit d'un véritable BAV II ou d'un faux diagnostic dû à une configuration correspondant à l'un des cas précités et, dans l'affirmative, à suspendre le traitement du BAV II par inhibition de tout passage indésirable en mode DDD.The first technique, illustrated by the flowchart in Figure 5, is, when a probable diagnosis of BAV II, to analyze the circumstances that led to this diagnosis of BAV to determine if it is a true BAV II or a false diagnosis due to a configuration corresponding to one of the aforementioned cases and, if so, to suspend the treatment of BAV II by inhibiting any undesirable passage in DDD mode.
Outre les abréviations indiquées plus haut (StimA, DetR, etc.), on désignera C1 et C2 deux compteurs particuliers mis en oeuvre par cet organigramme.In addition to the abbreviations indicated above (StimA, DetR, etc.), C1 and C2 will be designated two particular counters implemented by this flowchart.
Le compteur C1 est un compteur initialisé par exemple à 12 (correspondant dans ce cas au numérateur du rapport 12/9 entre le nombre d'ondes P non extrasystoliques et le nombre d'ondes R non extrasystoliques utilisé pour le diagnostic de BAV II comme exposé plus haut). L'initialisation de ce compteur est effectuée lors de la détection d'une ESV suspecte, survenant en fin d'IEA et correspondant au cas indiqué plus haut de stimulation en fenêtre de sécurité, ou au cas d'une ESV dont le couplage est tel qu'elle survient en même temps que la fin de l'IEA.The counter C1 is a counter initialized for example at 12 (corresponding in this case to the numerator of the ratio 12/9 between the number of waves Non-extrasystolic P and the non-extrasystolic R wave count used for the diagnosis of BAV II as explained above). Initialization of this counter is performed when a suspicious ESV is detected, occurring at the end of IEA and corresponding to the case indicated above of stimulation in the security window, or in the case of an ESV whose coupling is such that it occurs at the same time as the end of the IEA.
Ce compteur C1 est décrémenté d'une unité à chaque événement ventriculaire associé à un événement auriculaire ou à chaque ESV dont l'intervalle de couplage présente une durée notablement différente de celle de l'IEA.This counter C1 is decremented by one unit at each ventricular event associated with an atrial event or each ESV whose interval The coupling time is significantly different from that of IEA.
Lorsque le compteur C1 atteint une valeur nulle, ceci signifie que depuis douze cycles les événements ventriculaires survenus sont soit des dépolarisations associées à un événement auriculaire correspondant, soit des ESV qui ne surviennent pas en fin d'IEA ; on peut ainsi lever la suspicion de BAV sur des ESV survenant en fin d'IEA.When the counter C1 reaches a zero value, this means that since twelve cycles the ventricular events occurred are either depolarizations associated with a corresponding atrial event, that is, ESVs that do not occur at the end of IEA; we can lift the suspicion BAV on ESVs occurring at the end of IEA.
Le compteur C2, quant à lui, est par exemple initialisé à 12 (valeur donnée à tire d'exemple, définie de la même façon que pour le compteur C1), cette initialisation intervenant lorsque l'algorithme détecte soit une stimulation en fenêtre de sécurité, soit une ESV survenant en fin d'IEA, et qu'une stimulation auriculaire bloquée a été analysée au cours des douze derniers cycles.The counter C2, for its part, is for example initialized to 12 (given value for example, defined in the same way as for the counter C1), this initialization occurring when the algorithm detects is a stimulation in a security window, ie an ESV occurring at the end of the IEA, and a blocked atrial pacing has been analyzed in the last 12 cycles.
Ce compteur C2 est décrémenté d'une unité sur tout événement ventriculaire.This counter C2 is decremented by one unit on any ventricular event.
Lorsque C2 > 0, le diagnostic de BAV II est inhibé. Lorsque C2 devient égal à 0, alors le diagnostic de BAV II est avéré.When C2> 0, the diagnosis of BAV II is inhibited. When C2 becomes equal to 0, then the diagnosis of BAV II is proven.
Plus précisément, lors de la détection d'une ESV, le dispositif mesure l'intervalle entre la dernière onde P et la survenue de cette ESV (intervalle [P,ESV]). Si cet intervalle est voisin de la durée de l'IEA, typiquement si l'on a : IEA - 63 ms < [P,ESV] < IEA, alors un indicateur de suspicion de faux diagnostic est positionné à '1' (indicateur repéré "flag suspicion faux diag" sur l'organigramme de la figure 5). Lors d'une stimulation en fenêtre de sécurité, cet indicateur de suspicion est également positionné à '1'.More precisely, during the detection of an ESV, the device measures the interval between the last wave P and the occurrence of this ESV (interval [P, ESV]). If this interval is close to the duration of the IEA, typically if one has: IEA-63 ms <[P, ESV] <IEA, then an indicator of suspicion of false diagnosis is set to '1' (flag spotted "flag suspicion false diag" on the flowchart of Figure 5). During a safety window stimulation, this suspicion indicator is also set to '1'.
Si le compteur C2 de stimulations auriculaires bloquées est supérieur ou égal à 1, et que l'indicateur de suspicion de faux diagnostic est également à '1', alors le diagnostic de BAV II est inhibé pendant une durée donnée, par exemple typiquement pendant douze cycles. Ainsi, avec trois stimulations auriculaires bloquées sur douze, on ne déclenche pas de basculement en mode DDD - alors qu'avec un dispositif classique on provoquerait une telle commutation.If the counter C2 of blocked atrial stimulations is greater or equal to 1, and that the indicator of suspicion of false diagnosis is also to '1', then the diagnosis of BAV II is inhibited for a given duration, for example typically for twelve cycles. So with three stimulations ears locked on twelve, we do not trigger a tilt in DDD mode - while with a conventional device one would provoke such switching.
Si le dispositif ne trouve aucune ESV de durée voisine de l'IEA (au sens indiqué plus haut) ou aucune stimulation en fenêtre de sécurité, et qu'aucune stimulation auriculaire bloquée n'est détectée pendant, par exemple, douze cycles, alors l'indicateur de suspicion de faux diagnostic est remis à zéro, de même que le compteur C2.If the device does not find any ESV of duration close to the IEA (in the sense indicated above) or no stimulation in safety windows, and no blocked atrial pacing is not detected during, for example, twelve cycles, then the indicator of suspicion of false diagnosis is given to zero, as well as the counter C2.
Sur toute détection d'un quelconque des trois événements décrits précédemment (c'est-à-dire d'un évènement qui provoque le positionnement à '1' de l'indicateur de suspicion de faux diagnostic), alors le compteur C1 d'inhibition du diagnostic de BAV II est réinitialisé à la valeur typique d'origine, c'est-à-dire à 12 dans l'exemple donné plus haut. Ceci a pour effet de suspendre le basculement en mode DDD, le diagnostic de BAV II n'ayant pas été avéré.On any detection of any of the three events previously described (that is, an event that causes the positioning to '1' of the indicator of suspicion of false diagnosis), then the counter C1 BAV II diagnostic inhibition is reset to the original typical value, that is, at 12 in the example given above. This has the effect to suspend the switchover in DDD mode, the diagnosis of BAV II has not been proven.
Une seconde technique consiste, lors de la détection d'une ESV proche de la fin de l'IEA (au sens indiqué ci-dessus pour la première technique), ou d'une stimulation en fenêtre de sécurité, à prolonger l'intervalle d'échappement auriculaire IEA, par exemple d'une durée de 63 ms. Le prolongement de l'intervalle d'échappement permet d'éviter tout conflit entre une détection correcte de l'ESV et un comportement AAI satisfaisant.A second technique consists in detecting an ESV close to the end of the IEA (in the sense indicated above for the first technique), or in a safety window stimulation, to prolong the interval of IEA escape, for example of a duration of 63 ms. Extending the escape interval avoids any conflict between proper detection of the ESV and satisfactory AAI behavior.
Ce prolongement perdurera pendant un temps donné, par exemple pendant douze cycles, à moins que l'un des deux évènements ci-dessus ne soit à nouveau détecté par le dispositif.This prolongation will continue for a given time, for example during twelve cycles, unless one of the two events above is again detected by the device.
Claims (17)
dispositif caractérisé en ce qu'il comprend en outre :
characterized in that it further comprises:
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FR0304932A FR2854080B1 (en) | 2003-04-22 | 2003-04-22 | ACTIVE IMPLANTABLE MEDICAL DEVICE SUCH AS CARDIAC STIMULATOR, DEFIBRILLATOR AND / OR CARDIOVECTOR TYPE AAI OR AAI / DDD |
FR0304932 | 2003-04-22 |
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EP (1) | EP1470836B1 (en) |
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EP1731194A2 (en) * | 2005-06-09 | 2006-12-13 | Ela Medical | Active implantable medical device such as pacemaker, defibrillator and/or cardiovertor of type AAI or AAI/DDD, with ventricular tachycardia detection means |
EP1731195A1 (en) * | 2005-06-09 | 2006-12-13 | ELA MEDICAL (Société anonyme) | Active implantable medical device with AAI/DDD mode switching, in particular pacemaker, with improved control of mode switching in the presence of uncertain ventricular events |
EP2263747A1 (en) | 2009-06-15 | 2010-12-22 | Sorin CRM SAS | Implantable cardiac prosthesis comprising means for analysing patient's tolerance of stimulation mode aiming at spontaneous atrio-ventricular conduction |
US8131043B2 (en) | 2005-09-16 | 2012-03-06 | The Ohio State University | Method and apparatus for detecting interventricular dyssynchrony |
US8280136B2 (en) | 2005-09-16 | 2012-10-02 | The Ohio State University | Method and apparatus for detecting intraventricular dyssynchrony |
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US20010029392A1 (en) * | 2000-02-29 | 2001-10-11 | Marcel Limousin | Active implantable medical device of the defibrillator/cardiovertor type with sophisticated management of ventricular tachycardias |
US20020095183A1 (en) * | 2000-11-08 | 2002-07-18 | Cyrille Casset | Detection of a risk of a fusion situation in an active implantable medical device |
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2003
- 2003-04-22 FR FR0304932A patent/FR2854080B1/en not_active Expired - Fee Related
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2004
- 2004-04-09 AT AT04290953T patent/ATE352347T1/en not_active IP Right Cessation
- 2004-04-09 EP EP04290953A patent/EP1470836B1/en not_active Expired - Lifetime
- 2004-04-09 DE DE602004004435T patent/DE602004004435T2/en not_active Expired - Lifetime
Patent Citations (2)
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US20010029392A1 (en) * | 2000-02-29 | 2001-10-11 | Marcel Limousin | Active implantable medical device of the defibrillator/cardiovertor type with sophisticated management of ventricular tachycardias |
US20020095183A1 (en) * | 2000-11-08 | 2002-07-18 | Cyrille Casset | Detection of a risk of a fusion situation in an active implantable medical device |
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
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EP1731194A2 (en) * | 2005-06-09 | 2006-12-13 | Ela Medical | Active implantable medical device such as pacemaker, defibrillator and/or cardiovertor of type AAI or AAI/DDD, with ventricular tachycardia detection means |
EP1731195A1 (en) * | 2005-06-09 | 2006-12-13 | ELA MEDICAL (Société anonyme) | Active implantable medical device with AAI/DDD mode switching, in particular pacemaker, with improved control of mode switching in the presence of uncertain ventricular events |
FR2886859A1 (en) * | 2005-06-09 | 2006-12-15 | Ela Medical Soc Par Actions Si | ACTIVE AAI / DDD ACTIVE IMPLANTABLE MEDICAL DEVICE, IN PARTICULAR A CARDIAC STIMULATOR, HAVING AN IMPROVED MANAGEMENT OF MODE SWITCHES IN THE PRESENCE OF UNCERTAIN VENTRICULAR EVENTS |
FR2886858A1 (en) * | 2005-06-09 | 2006-12-15 | Ela Medical Soc Par Actions Si | ACTIVE IMPLANTABLE MEDICAL DEVICE SUCH AS CARDIAC STIMULATOR, CARDIOVERTER AND / OR DEFIBRILLATOR TYPE AAI OR AAI / DDD DETECTION OF VENTRICULAR TACHYCARDIA |
JP2007014757A (en) * | 2005-06-09 | 2007-01-25 | Ela Medical Sa | Improved management of mode switching for aai/ddd type implantable device in presence of ventiricular events of uncertain nature |
EP1731194A3 (en) * | 2005-06-09 | 2008-03-05 | Ela Medical | Active implantable medical device such as pacemaker, defibrillator and/or cardiovertor of type AAI or AAI/DDD, with ventricular tachycardia detection means |
US7797045B2 (en) | 2005-06-09 | 2010-09-14 | Ela Medical S.A.S. | Management of mode switching for an AAI/DDD type implantable device in the presence of ventricular events of uncertain nature |
US8131043B2 (en) | 2005-09-16 | 2012-03-06 | The Ohio State University | Method and apparatus for detecting interventricular dyssynchrony |
US8280136B2 (en) | 2005-09-16 | 2012-10-02 | The Ohio State University | Method and apparatus for detecting intraventricular dyssynchrony |
EP2263747A1 (en) | 2009-06-15 | 2010-12-22 | Sorin CRM SAS | Implantable cardiac prosthesis comprising means for analysing patient's tolerance of stimulation mode aiming at spontaneous atrio-ventricular conduction |
US8874210B2 (en) | 2009-06-15 | 2014-10-28 | Sorin Crm Sas | Apparatus and method for analyzing patient tolerance to a stimulation mode favoring a spontaneous atrioventricular conduction |
US9504835B2 (en) | 2009-06-15 | 2016-11-29 | Sorin Crm Sas | Stimulation mode determination |
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DE602004004435D1 (en) | 2007-03-15 |
FR2854080A1 (en) | 2004-10-29 |
DE602004004435T2 (en) | 2007-11-29 |
EP1470836B1 (en) | 2007-01-24 |
FR2854080B1 (en) | 2005-06-24 |
ATE352347T1 (en) | 2007-02-15 |
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